A Randomized, Blinded, Bilateral Intraindividual, Vehicle-Controlled Trial of the Use of Photodynamic Therapy With 5-Aminolevulinic Acid and Blue Light for the Treatment of Actinic Keratoses of the Upper Extremities

Background/Objective: Actinic keratoses (AKs) on the upper extremities are difficult to treat. This study compares the efficacy and tolerability of photodynamic therapy (PDT) using 20% 5-aminolevulinic acid solution (ALA) and blue light versus ALA vehicle and blue light for the treatment of AKs of the dorsal hand and forearm. Methods: Subjects were treated twice at an eight-week interval by ALA with blue light on one hand and forearm and with ALA vehicle and blue light on the contralateral hand and forearm. ALA incubation time was two hours under occlusion. Efficacy and tolerability were compared. Results: The mean lesion count reductions (58.4 +/- 22.2% and 24.8 +/- 20.6% four weeks after the second treatment for the ALA and vehicle-treated sides, respectively) differed significantly (P=0.0004). Eleven of 15 subjects (73%) in the ALA-treated side achieved at least 50 percent reduction in lesion count compared to only two subjects (13%) in the vehicle-treated side four weeks after the second treatment. The difference was significant (P=0.0143). Photodamage grade reduction was also significant (P=0.0309) after the second treatment. Subject satisfaction was moderate to very satisfied (86.7%) on the ALA-treated side. Transient adverse events were significantly greater on the ALA-treated side for erythema (P=0.0011), edema (P=0.0199) and stinging and burning (P=0.0016) 48 hours after the first treatment. Conclusions: Two sessions of PDT using ALA with blue light is a moderately effective, well-tolerated treatment of actinic keratoses of the dorsal hand and forearm.